UnknownPhase 2

Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis

China120 participantsStarted 2023-01-15

Plain-language summary

Purpose：To observe and evaluate the clinical efficacy and safety of deep-sea fish oil in preventing acute radiation-induced esophagitis (ARIE). Methods and Materials：A total of 120 patients with esophageal cancer treated with radiotherapy were randomly assigned (1:1) to treatment or control group. In the treatment group, 1g deep-sea fish oil was oral administrated prophylactically twice a day，the control group was blank control. The clinical efficacy of deep-sea fish oil on prevention of ARIE was evaluated by comparing the differences in the occurrence time, the grade and incidence of ARIE. Additionally, the change in nutritional status was also investigated. Hemanalysis, liver function, kidney function changes， and adverse reactions were compared before and after treatment to evaluate the safety of deep-sea fish oil.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥18 years old, ≤70 years old, gender is not limited;
✓. Histological or cytological evidence of esophageal, lung, or breast cancer;
✓. ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy;
✓. Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy;
✓. PG-SGA score \<9;
✓. Not pregnant or breastfeeding;
✓. The subject must understand and sign the informed consent
✓. Have reading comprehension ability and can complete the questionnaire with medical assistance;

Exclusion criteria

✕. Prior radiation therapy;
✕. Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function;

What they're measuring

The duration from initiation of radiotherapy to the onset of acute radiation esophagitis

Timeframe: Approximately 2 months

Severity of acute radiation esophagitis

Timeframe: Approximately 2 months

Incidence of severe acute radiation esophagitis

Timeframe: Approximately 2 months

Trial details

NCT IDNCT06392971

SponsorFirst Affiliated Hospital of Chengdu Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-15

Contact for this trial

Ke Xu, Doctor

xuke@cmc.edu.cn

View on ClinicalTrials.gov More Radiation Toxicity trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥18 years old, ≤70 years old, gender is not limited;
✓. Histological or cytological evidence of esophageal, lung, or breast cancer;
✓. ECOG score of 0-2, no swallowing pain or severe dysphagia before radiotherapy;
✓. Liver and kidney function, bone marrow function and cardiopulmonary function are not contraindicated by radiotherapy and chemotherapy;
✓. PG-SGA score \<9;
✓. Not pregnant or breastfeeding;
✓. The subject must understand and sign the informed consent
✓. Have reading comprehension ability and can complete the questionnaire with medical assistance;

Exclusion criteria

✕. Prior radiation therapy;
✕. Patients with severe underlying diseases, who cannot tolerate radiotherapy and chemotherapy due to severe liver and kidney insufficiency and poor cardiopulmonary function;